The following data is part of a premarket notification filed by Expanding Innovations, Inc. with the FDA for X-pac Expandable Lumbar Cage System.
| Device ID | K201145 |
| 510k Number | K201145 |
| Device Name: | X-Pac Expandable Lumbar Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Expanding Innovations, Inc. 110 Pioneer Way, Suite I Mountain View, CA 94041 |
| Contact | Mbithi Muthini |
| Correspondent | Nancy Lince Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, CA 95483 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-29 |
| Decision Date | 2020-09-10 |